SC directs FDA to conduct hearing on contraceptive drugs, implants

SC directs FDA to conduct hearing on contraceptive drugs, implants

Posted by on Sep 15, 2016 in Breaking News

by Rey G. Panaligan
September 13, 2016

The Supreme Court (SC) has struck down “as violative of the constitutional right to due process” the certifications and re-certifications issued by the Food and Drug Administration (FDA) for 77 contraceptive drugs and implants.

In a press briefing, Spokesman Theodore O. Te said the SC directed the FDA to conduct public hearing on the contraceptive drugs and implants, including Implanon and Implanon NXT, to determine whether they are abortifacients or non-abortifacients.

“The Court found that the FDA-certified, procured and administered contraceptive drugs and devices, without the observance of the basic tennets of due process, without notice and without public hearing, despite the constant opposition of petitioners,” Te said quoting from the SC resolution.

The SC said that “though the law creating the FDA vests it with power as the primary agency to determine whether a contraceptive drug or certain device has no abortifacient effects, its findings and conclusions should be allowed to be questioned and those who oppose the same must be given a genuine opportunity to be heard.”

“Due to the failure of the respondents to observe and comply with the basic requirements of due process, the Court is of the view that the certifications and re-certifications and the distribution of the questioned contraceptive drugs should be struck down as violative of the constitutional right to due process,” the SC ruled.

With the ruling written by Justice Jose Catral Mendoza, the SC denied the government’s plea to lift its restraining order against “procuring, selling, distributing, dispensing and administering, advertising and promoting” contraceptive implants.

Te said the case filed by the Alliance for the Family Foundation Philippines, Inc. (AFFPI) and Maria Conception Noche against the contraceptive implants has been ordered remanded to the FDA for hearing.

Te said the SC has ordered the FDA “to observe the basic requirements of due process by conducting a hearing and allowing the petitioners to be heard, on the re-certified, procured, and administered contraceptive drugs and devices, including Implanon and Implanon NXT, and to determine whether they are abortifacients or non-abortifacients.”

He also said the SC directed the FDA “to formulate the rules of procedure in the screening, evaluation, and approval of all contraceptive drugs and devices that will be used under Republic Act No. 10354,” the Responsible Parenthood and Reproductive Health (RH) Act of 2012.

The Department of Health (DOH), on the other hand, was directed “to generate the complete and correct list of the government’s reproductive health programs and services under RA 10354 which will serve as the template for the complete and correct information standard….”